False Claims Act (FCA) Office of the Inspector General

News & Analysis as of

Tenth Circuit Elaborates Upon FCA’s Materiality Requirement

The FCA’s implied certification theory is based on the concept that every time a payee submits a claim to the government it has impliedly certified compliance with all contractual, statutory, and regulatory obligations, and...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

OIG Issues New Guidance on Its Evaluation Process and Non-Binding Criteria for Section 1128(b)(7) Exclusions

On April 18, 2016, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a revised policy statement applicable to exclusions imposed under Section 1128(b)(7) of the Social Security Act...more

Final 60-day Overpayment Rule

On February 12, 2016, CMS published a final rule addressing compliance with Section 1128J(d) of the Social Security Act. Section 1128J(d), which was added when the Affordable Care Act was enacted on March 23, 2010, imposes a...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

OIG Issues Fall 2015 Semiannual Report to Congress

The HHS Office of Inspector General (OIG) has issued its Semiannual Report to Congress covering April 1 – September 30, 2015. The report summarizes significant OIG audits, investigations, and enforcement activities during...more

Ignorance is Not Bliss: Get to Know the OIG FY 2016 Work Plan

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect...more

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

The FCA Impact Of DOJ’s Increased Focus on Small Business

In 2014, the Small Business Administration reported that almost a quarter of approximately $367 billion of eligible funding for small business contracting, or roughly $91.7 billion, was awarded to small businesses as prime...more

Legal Risks Facing Nursing Home Providers and Reducing Risk with Clinical Documentation

Documentation in Electronic Health Records: - Nursing homes lag behind other providers in electronic health record system adoption - Of 472 nursing homes in New York, there was a 7.7 percent increase in EHR adoption...more

Millennium Health and DOJ Settle False Claims Act Allegations for $256 Million

On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more

OIG Targets Questionable Billing Practices for Ambulance Services

The Office of the Inspector General (“OIG”) pulled no punches in a recent report on Medicare Part B billing for ambulance transports. The September release presented a case for increased scrutiny, pointing out that Medicare...more

Beware the Feds: Emerging Risks to Health Care Executives Under the Yates Memo

Last month’s “Yates Memo” from the Department of Justice (DOJ) promises to be a game-changer in the world of government investigations and enforcement activity. While several U.S. Attorney Offices had been applying many of...more

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases: October 2015

Trends & Analysis: ..We have identified 15 health care–related qui tam cases that were unsealed since our last Qui Tam Update. Of those, 12 were filed from 2012 to the present. All but two cases had been pending more...more

Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post-Tuomey?

After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more

True Health Diagnostics to Acquire Health Diagnostic Laboratory

A U.S. Bankruptcy Court judge has approved the sale of Health Diagnostic Laboratory (HDL), based in Richmond, Va., to True Health Diagnostics, based in Frisco, Texas, for $37.1 million, according to a Richmond Times Dispatch...more

Prosecuting Doctors for Medicare Fraud

Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more

Hospitals Accused of Violating the False Claims Act Through Ownership of the PPO For Their Self-Funded Employee Health Plans

On August 27, 2015, following notification by the government that it had decided not to intervene, the United States District Court for the Middle District of North Carolina, ordered that a qui tam complaint charging...more

When the Government Comes Knocking

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Healthcare Legal News: Volume 5, Number 3

RESPONDING TO SUBPOENAS AND OTHER REQUESTS FOR PERSONAL HEALTH INFORMATION: TAKE THEM AT FACE VALUE - Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from...more

Physician Compensation Arrangements Under The Microscope

On June 9, 2015, the United States Department of Health and Human Services Office of Inspector General (OIG) issued a Fraud Alert titled, "Physician Compensation Arrangements May Result in Significant Liability," focusing on...more

Stark Litigation: The Tuomey Saga Draws to a Close

In what may be the penultimate chapter of the long–running saga of the Tuomey case, the Fourth Circuit affirmed the final judgment and award in favor of the government in its case against Tuomey Healthcare System, Inc....more

Government Contracts Quarterly Update - July 2015

The Government Contracts Quarterly Update is published by BakerHostetler’s Government Contracts Practice team to inform our clients and friends of the latest developments in federal government contracting. Please see...more

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